Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments, see Pages 2-7, filed 07/06/2026, with respect to the 102 rejection of claims 1, 9, 14, 16 and 20-27 over Docherty et al. (AU 2020205272 A1) and the 103 rejection of claims 3-8, 10-13, 15, 17-19 and 28 over Docherty et al. (AU 2020205272 A1) in view of Bains (WO 2020061584 A1), Ridall et al. (US 20180369221 A1), Williams (US Patent No. 20200061138), Hallow et al. (WO 2020051371 A1), Donaduzzi et al. (WO 2019153064 A1), Rosenbaum et al. (US Patent No. 20190307675) and Bastos et al. (WO 2020171727 A2 have been fully considered and are persuasive. The rejection of claims 1 and 3-28 has been withdrawn.
Applicant has cancelled claims 11-12 and 14-15. Claims 1, 3-10, 12-13 and 16-28 is pending. Claims 1, 3-10, 12-13 and 16-28 is now evaluated on its merits.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3-10, 13 and 16-28 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claim 1, in which all the preceding claims depends from recites “A method of treating Alzheimer's disease and/or other neurodegenerative disorder in a subject, comprising: administering to the subject in need thereof, via the oral mucosa, a rapidly infusing composition comprising (a) a pharmaceutically acceptable binder and/or excipient system comprising gelatin and a sugar alcohol, and (b) a therapeutically effective amount of solid form cannabidiol (CBD) having a purity between 95 and 99.9 wt.% or a derivative/analog thereof, wherein the rapidly infusing composition is lyophilized”. From applicants’ specifications there are no examples or testing of the claimed composition to treat Alzheimer's disease and/or other neurodegenerative disorders. Applicant directs the clinical trial of the claimed composition to the treatment of post-surgical pain and the known studies done with claimed composition for the treatment of Alzheimer's disease and/or other neurodegenerative disorders composed of CBD oil in high concentrations.
The treatment of Alzheimer's disease and/or other neurodegenerative disorders as well as their symptoms is a vast and wide category which encompass many different types of therapeutics which have varied in percentage of meaningful treatment. According to Alzheimer’s Research Association (Alzra, Can CBD Treat Some Alzheimer’s Symptoms?, Alzheimer’s Research Association, September 2022) there is currently no scientific evidence that CBD products can assist in curing or preventing Alzheimer’s disease symptoms, additionally there is no known treatment for dementia or Alzheimer’s. Thus, applicant lacks enablement for the claimed low concentration solid CBD composition for the treatment of Alzheimer's disease and/or other neurodegenerative disorders.
Conclusion
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MIKHAIL O'DONNEL. ROBINSON
Examiner
Art Unit 1627
/MIKHAIL O'DONNEL ROBINSON/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
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